Competence Enhancement through collaborations in clinical studies, regulatory, health economics & reimbursement
| Reference number | |
| Coordinator | IAROCA AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | May 2025 - November 2025 |
| Status | Ongoing |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Competence Enhancement in Small Businesses 2025 |
Purpose and goal
Collaboration between Acorai (IAROCA AB) and GBA Key2Compliance AB in clinical reporting, preparation for upcoming clinical studies, regulatory and reimbursement. The goal of the project is an increased internal understanding of these processes, while the expertise of Key2Compliance will support future milestones. Transfer of expertise takes place through: 1) Collaboration between Key2Compliance and Acorai 2) Meeting in Helsingborg or Stockholm 3) Material produced by Key2Compliance
Expected effects and result
The expected results are: - Thoroughly developed results of CAPTURE-HF (previous clinical study) - Preparations for upcoming clinical studies - Work with FDA & CE mark - Greater understanding of health economics - Knowledge transfer to Acorai - Updated reimbursement strategy & plan
Planned approach and implementation
The project is carried out in two work packages: 1) Clinical reporting and preparation within clinical studies & regulatory: reporting of previous CAPTURE-HF study, preparations for upcoming clinical studies, work with quality and regulatory and discussions on health economics. 2) Reimbursement and market: further development of reimbursement strategy, including discussions and research on improvement opportunities. Compilation of updated reimbursement plan.